Manager of Document Control

Job Summary

Overseeing document control and training processes, the full-time Manager of Document Control will ensure compliance with corporate policies and regulations while supporting quality systems in a remote environment.

Key Responsibilities

• Manage daily operations and lead improvements in the Quality Management System (QMS), focusing on Document Change Control and Training for GxP compliance
• Support Document Control activities for GxP operations and facilitate the creation and revision of controlled documents
• Act as the subject matter expert for the document change control system and training program, assisting in inspection readiness and audit activities

Required Qualifications

• 8+ years of experience in QA Quality Systems and documentation processes in the drug, biopharmaceutical, or medical device fields
• Experience with electronic document control systems compliant with FDA 21 CFR Part 11
• Knowledge of FDA regulations and ICH guidance for drugs, biologics, and devices
• Strong organizational and management skills with the ability to prioritize multiple projects
• Proficient in applicable software, including MS Windows and MS Office